[Federal Register Volume 60, Number 16 (Wednesday, January 25, 1995)]
[Notices]
[Pages 4916-4918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1807]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health
[Announcement Number 521]


Occupational Radiation and Energy-Related Health Research Grants; 
Notice of Availability of Funds for Fiscal Year 1995

Introduction

    The Centers for Disease Control and Prevention (CDC), National 
Institute for Occupational Safety and Health (NIOSH), announces that 
applications are being accepted for research projects relating to 
occupational safety and health concerns associated with occupational 
exposures to radiation and other hazardous agents at nuclear facilities 
and in other energy-related industries. Studies in the nuclear power 
industry and deliberate exposure of human subjects in radiation 
experiments are outside the scope of this announcement.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led national activity to reduce morbidity and mortality 
and improve the quality of life. This announcement is related to the 
priority area of Occupational Safety and Health. (For ordering a copy 
of ``Healthy People 2000,'' see the section ``Where to Obtain 
Additional Information.'')

Authority

    This program is authorized under the Public Health Service Act, as 
amended, Section 301(a) (42 U.S.C. 241(a)) and the Occupational Safety 
and Health Act of 1970, Section 20(a) (29 U.S.C. 669[a]). The 
applicable program regulations are in 42 CFR Part 52.

Eligible Applicants

    Eligible applicants include domestic and foreign non-profit and 
for-profit organizations, universities, colleges, research 
institutions, and other public and private organizations, including 
State and local governments and small, minority and/or woman-owned 
businesses.

Smoke-Free Workplace

    The Public Health Service strongly encourages all grant recipients 
to provide a smoke-free workplace and promote the non-use of all 
tobacco products. This is consistent with the PHS mission of promoting 
the protection and advancement of an individual's physical and mental 
health.

Availability of Funds

    Approximately $500,000 is available in FY 1995 to fund 
approximately 3 to 5 research project grants (R01). The amount of 
funding available may vary and is subject to change. Awards will range 
from $25,000 to $200,000 in total costs (direct and indirect) per year. 
Awards are expected to begin on or about September 1, 1995. Awards will 
be made for a 12-month budget period within a project period not to 
exceed 3 years. Continuation awards within the project period will be 
made on the basis of satisfactory progress and availability of funds.

Purpose

    NIOSH will support applied field research projects to identify and 
investigate the relationships between health outcomes and occupational 
exposure to radiation and other hazardous agents; epidemiologic methods 
research relevant to energy-related occupational health research; and 
research related to assessing occupational exposures.

Programmatic Interest

    The focus of grants should reflect the following topical areas, 
emphasizing field research: (1) Occupational exposure assessment, (2) 
radiation measurement issues, (3) non-cancer morbidity and mortality 
outcomes, (4) meta-analysis and combined analysis methodologies, (5) 
uncertainty analysis, (6) effects of measurement error on risk 
estimates, and (7) studies of current workers.

(1) Retrospective Exposure Assessment

    Epidemiologic studies of occupational cohorts frequently involve, 
and can generally benefit from, retrospective exposure assessment to 
provide estimates of exposure or categorize groups of workers by common 
exposure. Exposure assessment in energy-related occupational 
epidemiology requires evaluating exposures to various hazards including 
ionizing and non-ionizing radiation, metals, acids, and solvents. Grant 
opportunities encompass the fields of industrial hygiene and 
retrospective exposure assessment of health physics dosimetry. Research 
areas of general interest include: Methods to use limited data to best 
advantage; how to treat censored data in retrospective exposure 
assessment; uncertainty analysis techniques for industrial hygiene 
exposure data and health physics dosimetry; insight to sampling 
strategy design yielding a representative understanding of exposed 
groups; decision logic to select/use the most appropriate exposure 
metric for epidemiologic and risk assessment use; and, development 
approaches of ``Homogeneous Exposed Groupings'' and the advantages/
limitations for epidemiologic use. Research opportunities of specific 
interest include: reconstruction and dose adjustment of historic film 
badges; exposure assessment for acid mists, carcinogenic solvents, 
exotic metals, and leukemogens; assessment of electromagnetic field 
exposure; and evaluation of biomarkers of exposure.

(2) Radiation Measurement Issues

    This topic will focus on the applicability and utility of radiation 
dose data in epidemiological research. Examples of such issues include 
how to use nondetectable values and missing dose data in historical 
radiation exposure measurements, the accuracy of historical external 
dosimetry techniques (film and pocket dosimeters), combining external 
and internal doses into a useful index, historical bioassay, and 
radiochemistry techniques.

(3) Non-cancer Morbidity and Mortality Outcomes

    The majority of analytical epidemiologic research of health effects 
of energy-related occupational and environmental exposures has focused 
historically on the assessment of the association between cancer 
mortality and exposure to ionizing radiation. Although the importance 
of this research should not be underestimated, it is essential that 
other potential adverse health effects, as well as other possible 
energy-related exposures, be thoroughly evaluated as well. Among these 
would be the possible effects of radiation on the reproductive, 
neurologic, and immune systems. Chemical exposures highly prevalent in 
Department of Energy facilities, such as beryllium and mercury, have 
also been associated with a variety of disease outcomes, particularly 
respiratory and neurologic in nature. [[Page 4917]] 

(4) Meta-Analysis and Combined Analysis Methodologies

    Many of the cohorts at nuclear facilities are not individually 
large enough to detect statistically significant increases in mortality 
or incidence for rare cancer types. Methods and/or analyses for 
combining data across studies, whether in summary form or individual 
data, are valuable to the NIOSH research effort involving energy-
related health research.

(5) Uncertainty Analysis

    Measures of occupational exposure are inherently uncertain. Even 
when measures of external radiation exposure are generally available, 
the models, used to estimate organ dose, shallow versus deep dose, 
neutron dose, etc., are subject to error. Measures of dose derived from 
biological monitoring of urine, feces, blood, etc., are even less 
precise. Methods for assessing the degree of error in various estimates 
of exposure to both ionizing radiation as well as other toxic agents 
(chemicals, EMF, etc.) are desirable.

(6) Effects of Measurement Error on Risk Estimates

    Estimation of both bias and imprecision introduced into risk 
analyses through exposure measurement error have recently received 
considerable attention. Many of the suggested approaches are very 
computer intensive. Practical solutions to this problem with regard to 
the spectrum of epidemiologic designs (cohort, case-control, cross-
sectional, etc.) are needed, with particular attention to the nature of 
exposure measurement in radiation epidemiology.

(7) Studies of Current Workers

    Much of the epidemiologic research on nuclear workers conducted at 
nuclear facilities and other sites has emphasized retrospective 
studies. More recently new activities involve environmental 
restoration, waste management and other work that is not related to the 
design and production of nuclear weapons. Workers are being exposed to 
radiation and other hazardous agents under conditions and in processes 
not previously encountered. Exposure assessment, epidemiologic and 
related studies are needed to evaluate these new conditions and 
processes and the impact on worker health.

Inclusion of Minorities and Women in Study Populations

    Applicants are required to give added attention (where feasible and 
appropriate) to the inclusion of minorities and/or women study 
populations for research into the etiology of diseases, research in 
behavioral and social sciences, clinical studies of treatment and 
treatment outcomes, research on the dynamics of health care and its 
impact on disease, and appropriate interventions for disease prevention 
and health promotion. Exceptions would be studies of diseases which 
exclusively affect males or where involvement of pregnant women may 
expose the fetus to undue risks. If minorities and/or women are not 
included in a given study, a clear rationale for their exclusion must 
be provided.

Evaluation Criteria

    Upon receipt, applications will be reviewed for completeness and 
responsiveness by NIOSH. Incomplete applications will be returned to 
the applicant without further consideration. If NIOSH staff finds that 
the application is not responsive to this announcement, it will be 
returned without further consideration. If the proposed project 
involves organizations or persons other than those affiliated with the 
applicant organization, letters of suport and/or cooperation must be 
included.
    Applications that are complete and responsive to this announcement 
will be evaluated for scientific and technical merit by an appropriate 
peer review group convened by the CDC in accordance with the review 
criteria stated below. As part of the initial merit review, a process 
(triage) may be used by the initial review group in which applications 
will be determined to be competitive or non-competitive based on their 
scientific merit relative to other applications received in response to 
this announcement. Applications judged to be competitive will be 
discussed and be assigned a priority score. Applications determined to 
be non-competitive will be withdrawn from further consideration and the 
principal investigator/program director and the official signing for 
the applicant organization will be promptly notified.
    Review criteria for this announcement is the same as those for 
unsolicited research grant applications:

--Scientific, technical, or medical significance and originality of 
proposed research;
--Appropriateness and adequacy of the experimental approach and 
methodology proposed to carry out the research;
--Qualifications and research experience of the Principal Investigator 
and staff, particularly but exclusively in the area of the proposed 
research;
--Availability of resources necessary to perform the research;
--Adequacy of plans to include both genders and minorities and their 
subgroups as appropriate for the scientific goals of the research. 
Plans for the recruitment and retention of subjects will also be 
evaluated.

    The review group will critically examine the submitted budget and 
will recommend an appropriate budget and period of support for each 
scored application.
    In the secondary (programmatic importance) review, the following 
factors will be considered:
    1. Results of the initial review;
    2. Magnitude of the problem in terms of numbers of workers 
affected;
    3. Severity of the disease or injury in the worker population; and
    4. Usefulness to applied technical knowledge in the identification, 
evaluation, and/or control of occupational safety and health hazards.
    Applicants will compete for available funds with all other approved 
applications. The following will be considered in making funding 
decisions:
    1. Quality of the proposed project as determined by peer review;
    2. Availability of funds; and
    3. Program balance among research areas of the announcement.

Executive Order 12372--Review

    Applications are not subject to the review requirements of 
Executive Order 12372, entitled Intergovernmental Review of Federal 
Programs.

Public Health System Reporting Requirement

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.262.

Other Requirements

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations (45 CFR part 46) regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing assurance in accordance with the appropriate 
[[Page 4918]] guidelines and form provided in the application kit.

Application Submission and Deadlines

A. Preapplication Letter of Intent

    Although not a prerequisite of application, a non-binding letter of 
intent-to-apply is requested from potential applicants. The letter 
should be submitted to the Grants Management Officer (whose address is 
reflected in section B, ``Applications''). It should be postmarked no 
later than March 15, 1995. The letter should identify the announcement 
number, name of principal investigator, and specify the priority area 
to be addressed by the proposed project. The letter of intent does not 
influence review or funding decisions, but it will enable CDC to plan 
the review more efficiently, and will ensure that each applicant 
receives timely and relevant information prior to application 
submission.

B. Applications

    Applicants should use Form PHS-398 (OMB Number 0925-0001) and 
adhere to the ERRATA Instruction Sheet for Form PHS-398 contained in 
the Grant Application Kit. Please submit an original and five copies on 
or before April 19, 1995 to: Henry S. Cassell, III, Grants Management 
Officer, Procurement and Grants Office, Centers for Disease Control and 
Prevention, (CDC), 255 East Paces Ferry Road, NE., Room 300, MS-E13, 
Atlanta, GA 30305.

C. Deadlines

    1. Applications shall be considered as meeting a deadline if they 
are either:
    A. Received at the above address on or before the deadline date, or
    B. Sent on or before the deadline date to the above address, and 
received in time for the review process. Applicants should request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or the U.S. Postal Service. Private 
metered postmarks shall not be accepted as proof of timely mailings.
    2. Applications which do not meet the criteria above are considered 
late applications and will be returned to the applicant.

Where To Obtain Additional Information

    All application procedures and guidelines are contained within the 
present announcement. Business management information may be obained 
from Lisa G. Tamaroff, Grants Management Specialist, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC), 255 
East Paces Ferry Road, NE., MS-E13, Atlanta, GA 30305, telephone (404) 
842-6796. Programmatic technical assistance may be obtained from Roy M. 
Fleming, Sc.D., Associate Director for Grants, National Institute for 
Occupational Safety and Health, Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE., Building 1, Room 3053, MS-
D30, Atlanta, GA 30333, telephone (404) 639-3343.
    When requesting information, please refer to announcement number 
521.
    Potential applicants may obtain a copy of Healthy People 2000 (Full 
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary 
Report, Stock No. 017-001-00473-1) through the Superintendent of 
Documents, Government Printing Office, Washington, DC 20402-9325, 
telephone (202) 783-3238.

    Dated: January 18, 1995.
Linda Rosenstock,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 95-1807 Filed 1-24-95; 8:45 am]
BILLING CODE 4163-19-P